MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0022
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that two system screw implants were explanted after placement during a surgical procedure due to the internal yoke component of the implants not allowing for introduction of system rods.There were no known patient complications associated with this complaint.The surgeon elected to perform unilateral fixation with the successfully placed system screw implants.An rma# was issued for return of the complaint implants, which were received at the manufacturer on 12/18/2023 for complaint assessment.This report is associated with mdr# 3005031160-2023-00026.
Additional Manufacturer Narrative
A visual assessment of the returned system screws showed implants that had been placed and explanted.The anodization was worn in areas of the cup component as well as visible scratches present.The 3.5mm system yoke of both returned system screw implants were rotated approximately 90° from the intended orientation of the assembly.A functionality assessment was not performed, as the returned system screw implants will be discarded per procedure for devices that have been implanted.A dhr review was performed for system screw lot# 056543 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.The device lot has been available for distribution since 8/06/2018.The system screwdriver intended to be used for implantation of the system screw implants is designed to rotate the system screw implants as an assembly.The sub-assembly components (cup, yoke, and screw) of the system screw implants are press fit together to complete a system screw implant assembly.If the components of the system screw implants are not rotated as an assembly, it can allow the yoke and cup of the system screw implant assembly to rotate independently of one another, which would prevent rod introduction.The root cause of this complaint cannot be reliably determined.The complaint investigation suggests the possibility that the system screw implant cup component may have been rotated independently of the yoke, which prevented rod introduction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 18377650
• Report Number: 3005031160-2023-00025
• Device Sequence Number: 20760973
• Product Code: NKG
• UDI-Device Identifier: M697X06700221
• UDI-Public: M697X06700221
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X067-0022
• Device Lot Number: 056543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown